1. Name Of The Medicinal Product
Strepsils Orange with Vitamin C 100mg
STREPSILS Dry & Sore Throat
2. Qualitative And Quantitative Composition
Amylmetacresol BP 0.6mg
2,4
Vitamin C, (Ascorbic Acid, Sodium Ascorbate Equivalent to EP) 100.0mg
3. Pharmaceutical Form
Orange flavoured and coloured circular lozenge.
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of mouth and throat infections.
4.2 Posology And Method Of Administration
For oral administration.
Adults and children (over 6 years old):
One lozenge to be dissolved slowly in the mouth every 2
Not suitable for children under 6 years.
Elderly:
There is no need for dosage reduction in the elderly.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
Keep all medicines out of the reach of children.
If symptoms persist consult your doctor.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No clinically significant interactions are known.
4.6 Pregnancy And Lactation
The safety of Strepsils Orange with Vitamin C 100mg has not been established, but it is not considered to constitute a hazard.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects are known.
4.8 Undesirable Effects
Occasionally hypersensitivity reactions.
4.9 Overdose
Overdosage should not present a problem other than gastrointestinal discomfort.
Treatment should be symptomatic.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
2,4
Ascorbic acid provides a source of vitamin C, which may be beneficial during infection when vitamin C levels are believed to fall.
5.2 Pharmacokinetic Properties
None stated.
5.3 Preclinical Safety Data
None available.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Menthol natural or menthol synthetic
Tartaric acid
Bloodorange flavour 78300-34 Givaudan
Ppropylene glycol
Sunset yellow FCF (E110)
Ponceau 4R (E124)
Solids from liquid sugar demin (or from) liquid sugar T & L T1001
Liquid glucose BPC 1963.
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
36 months for lozenges packed in blister strips within a carton.
18 months for blister packs attached to a stencilled card.
24 months for lozenges packed in polypropylene tube, with an in-use shelf life of 'use within 3 months of opening'.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
A blister push
A blister push
A blister push
An injection moulded white pigmented polypropylene tube with an injection moulded white polyethylene cap (containing white silica gel that is sealed with a white cardboard disc).
The tube contains 10 lozenges.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 3UH
8. Marketing Authorisation Number(S)
PL 00063/0391
9. Date Of First Authorisation/Renewal Of The Authorisation
19th March 2010
10. Date Of Revision Of The Text
March 2010
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